FDA CRACKS DOWN ON DIETARY SUPPLEMENT PRODUCERS

In two separate incidences, the FDA has taken enforcement action against U.S. dietary supplement manufactures affecting production and halting manufacturing.  In one instance, the agency took legal action in the form of a permanent injunction against one dietary supplement maker, claiming the substitution of ingredients and products without noting the changes on the final product labels. This injunction stopped the production of more than 400 products.

In a second incident, U.S. marshals seized all dietary supplements produced by the maker for alleged false claims made about product safety and effectiveness in treating a number of diseases. In an FDA press release the agency stated that, “products are unapproved new drugs that may not be introduced into interstate commerce and are misbranded in violation of the Federal Food, Drug, and Cosmetic Act.”

Chilton Consulting Group has developed an extensive regulatory gap analysis spreadsheet for tracking 21 CFR 111 and 21 CFR 110  compliance and coupled that with policy manuals with customized procedures for each regulatory requirement. Contact CCG today should you need assistance with dietary supplement manufacturing compliance assistance.